TEMPLE, Texas, Nov. 26, 2013 /PRNewswire/ -- Unique Pharmaceuticals, Ltd., (UPI), a leading specialty compounding pharmacy, fully supports the recently passed Drug Quality and Security Act and applauds members of both chambers of congress for creating much-needed industry oversight and establishing more rigorous standards.
"Everyone at Unique Pharmaceuticals is committed to maintaining and exceeding the highest level of quality and safety for our customers," said Unique Pharmaceuticals President Travis A. Leeah, RPh, MBA, who has championed UPI's involvement with regulators on both the state and federal levels. "The legislation reflects a significant step forward and helps ensure the integrity of the customized, compounded sterile medications that are administered to patients in virtually all U.S. hospitals."
The full passage of the Drug Quality and Security Act brings definition to the regulation of the compounding industry by establishing a new oversight section of the U.S. Food and Drug Administration (FDA) for "outsourcing facilities" like Unique. This new category of large sterile compounders will be held to rigorous requirements and subject to routine FDA inspections.
Unique Pharmaceuticals is already registered with the FDA and makes significant investments of both capital and human resources to maintain the agency's standards. Unique's "Quality by Design" program additionally meets applicable Good Manufacturing Practices and as well as USP 797 standards.
In May, the company adopted Chemunex ScanRDI technology across their operations to confirm sterility of all preparations developed in their laboratory. UPI is one of the very few compounding pharmacies in the U.S. with the capability to detect and identify any microorganism in a raw ingredient or preparation – down to one microbial cell – within 48 hours. Compounders typically ship preparations to a third-party laboratory to confirm sterility requiring a 14-day incubation period before they are confirmed sterile and ready to be administered.
About Unique Pharmaceuticals, Ltd.
Unique Pharmaceuticals, Ltd., (UPI) is a PCAB Accredited™ specialty compounding pharmacy dedicated to improving quality of life and providing trusted preparations for clinics, hospitals and surgery centers throughout the United States. UPI has more than 15 years of industry experience and is ISO 9001:2008 certified, VAWD (Verified-Accredited Wholesale Distributors) accredited and USP Chapter 797 compliant. The company is headquartered in Temple, Texas, and is committed to delivering quality, assurance and peace of mind with every solution. For more information, please visit www.upisolutions.com or call 888-339-0874.
|SOURCE Unique Pharmaceuticals, Ltd.|
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